Unreported Paxil suicides: company abandons "No Addiction" claim

Unreported Paxil suicides: company abandons “No Addiction” claim

Sat, 10 May 2003

GlaxoSmithKline, Britain’s biggest pharmaceutical company will change the label in the UK to reflect the severe withdrawal that its antidepressant drug, Seroxat (Paxil in US) generates in many patients. In Britain, the package label will no longer claim that the Seroxat is not addictive.

Among the responders to the October expose were families who reported 16 suicides, 11 of them in the past two years, that they say have never been reported to the UK Medicines and Healthcare products Regulatory Agency (MHRA). The agency said it knows of only seven suicides of people on Seroxat over the past two years.

In the U.S. the Food and Drug Administration (FDA) acknowledges that it receives only 1% to 10% reports of adverse drug effects suffered by patients. Doctors–many of who receive financial inducements from drug companies, simply don’t report adverse drug reaction.

When will the FDA act to protect the American public by requiring drug companies to disclose fully the severe side effects induced by their drugs? Psychoactive drugs such as the SSRI antidepressants, the ‘atypical’ antipsychotics, and the psychostimulants such as, methylphenidate (Ritalin). To varying degrees they all induce severe physical and behavioral adverse side effects–including addiction. The SSRIs and antipsychotics induce extreme restlessness (akathisia) which leads some people–including children–to become violent.

At least 16 suicides of people who took the antidepressant Seroxat have gone unreported by their doctors in the past few years, it will be revealed this weekend, raising serious questions about the monitoring capabilities of the medicines regulator.

Concerns that Seroxat and others in the SSRI (selective serotonin re-uptake inhibitor) class, such as Prozac, could tip a minority towards suicide have been raised for a while.

In the US, two years ago, a jury awarded a family pounds 4.6m damages after concluding that the drug, known there as Paxil, caused Donald Schell to kill his wife, daughter, baby granddaughter and then himself.

The medicines and healthcare products regulatory agency, part of the Department of Health, collects reports from doctors on any side-effects or adverse reactions that might be linked to a prescription medicine. Neither patients nor their relatives can fill out a “yellow card” – recording problems – and not every doctor participates in the scheme as it is voluntary.

The BBC’s Panorama programme Emails from the Edge will reveal on Sunday that the phenomenal response – 67,000 phone calls and 1,400 emails – to its October documentary on Seroxat threw up reports of 16 suicides, 11 of them in the past two years, that have never been reported to the MHRA, as far as relatives are aware. The agency knows of only seven suicides of people on Seroxat over the past two years.

“In retrospect, when it is fully conceded that the drug can cause problems, this is going to look like a very serious failure,” said David Healy, director of the North Wales department of psychological medicine, who has taken evidence to the agency linking suicides to this class of drug.

He added: “Doctors have been getting the mantra from the drug companies for 12 years that it is the disease [causing the suicide] and not the drug. It does provide a nice way out for GPs who just don’t want to contemplate the possibility that a drug they prescribe could cause death.”

One of those who contacted Panorama was Graham Aldred from Cheshire, whose wife killed herself after 11 days on Seroxat. Rhona, 53, suffered nightmares and then began to behave out of character.

In a statement, the MHRA said the safety of anti-depressants was closely monitored but it would look at any data from the Panorama study that was made available to it.

Mind is critical of the Medicines and Healthcare products Regulatory Agency for failing in its duty fully to investigate the extent to which people experience side effects from Seroxat, including suicides that bereaved relatives believe are directly linked to the drug (GPs accused, May 9). For eight years Mind has campaigned for consumer reporting of side effects to psychiatric drugs. The MHRA is extending the yellow card scheme to the public through NHS Direct, but this is still too little too late. Whenever Mind campaigns on the safety of drugs, and the right for patients to be given full and unbiased information on the potential side effects, we are criticised by some groups who say we are scare-mongering. Why should we, and programme makers like Panorama, be silenced, when there is a real issue of public safety at the heart of our concerns? Millions of pounds are spent advertising psychiatric drugs, but who has the money to balance these messages? Panorama has given us, and the many people who have experienced horrific side effects or lost a loved one, the opportunity to get this issue the attention it deserves. We understand that many people say they find Seroxat beneficial, so we are not calling for an all-out ban. We are calling on the MHRA to stop doctors prescribing it to new patients until they undertake a full and independent review that includes the experiences of people taking it. Richard Brook Chief Executive, Mind

Seroxat maker abandons ‘no addiction’ claim

Firm agrees to alter leaflet to patients after complaints

Sarah Boseley, health editor Saturday May 3, 2003 The Guardian

The drug company which makes Seroxat, the antidepressant which thousands of people say they cannot give up because of severe withdrawal effects, is to drop the claim on its patient leaflet saying the drug is not addictive.

The admission of a change of policy from GlaxoSmithKline, Britain’s biggest pharmaceutical company, comes in a BBC Panorama programme to be shown on May 11.

Emails from the Edge examines the big response from Seroxat users to its first investigation, in October, of its withdrawal problems.

Seroxat is a commonly prescribed antidepressant of the SSRI (selective serotonin re-uptake inhibitor) class, to which Prozac also belongs.

Many people say it has changed their lives by lifting them out of depression, but some experience distressing side-effects when they try to reduce the dose and stop taking it. These effects are said to include sensations comparable to electric shock.

Last July the Guardian revealed that Seroxat topped the league table for complaints of side-effects made by doctors to the government’s committee on the safety of medicines under the yellow card scheme. A total of 1,281 complaints were filed – more than the combined amount for the rest of the top 20 most cited drugs.

The watchdog group Social Audit complained at the time about the wording on the Seroxat patient information leaflet. It states that “these tablets are not addictive”, and that withdrawal problems “are not common and not a sign of addiction”.

Alastair Benbow, head of European clinical psychiatry at GSK, says in the film that the wording was poorly understood by patients. Yesterday he told the Guardian that he accepted that the drug, like other medicines, did cause physiological changes. “It is absolutely right, some people have symptoms and for some those are very troubling.”

But GSK is unlikely to head off the mounting criticism because it intends to keep the advice issued in a separate information sheet to doctors which says the drug does not cause dependence.

David Healy, director of the North Wales department of psychological medicine, has long argued that the company should change its advice to doctors.

“If there is withdrawal, then there is physical dependence. There will be some people who will never be able to halt this drug, there will be some for whom halting will not be awfully difficult and some for whom it is a real issue.” The SSRIs were not like opiates such as heroin which causes drug depmcency as opposed to physical dependency, he said. They were more comparable to the benzodiazepines such as Valium, which is now prescribed only with great caution because of withdrawal problems.

Charles Medawar, of Social Audit, was not impressed by GSK’s move. “My feeling is that the changes GSK proposes could and should have been made at least five years ago and will not tell patients anything they don’t know. They are glossing over the reality. This is far too little, too late.”

Sarah Venn, of the Seroxat users group which has 4,000 members, said: “We are pleased to have this news but it doesn’t address the information provided to doctors. It doesn’t go anywhere near helping patients who are on this drug and can’t get off it.”

Some patients complain of doctors lacking sympathy when told about the side-effects.

But Dr Benbow said GSK’s “feedback” showed doctors did understand what was meant and he could see no reason to spell out the difference between “physical dependency” and “drug dependency”.

“I think we would start to get into difficulties of definition.” He said the wording of the doctors’ leaflet should only be changed “if we think there is a clear lack of understanding [by] the doctors,” he added.